dornase alfa
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | PULMOZYME | — | 1996-11-27 – 2014-12-12 | fda.gov ↗ |
| Approved | US (FDA) | PULMOZYME | — | 1993-12-30 | fda.gov ↗ |
Trials 27
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT00536952 | Feb 2008 → Oct 2014 | head and neck cancer | Northwestern University | Unknown | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT02135588 | Oct 2013 → Dec 2021 | cancer | Eastern Regional Medical Center | Unknown | No outcome recorded |
| Phase 211 trials · 1 met primary · 2 missed | ||||||
| Phase 2 | NCT06723717 | Sep 2025 → Mar 2028 expected | acquired aneurysmal subarachnoid hemorrhage, brain ischemia | Fondation Ophtalmologique Adolphe de Rothschild | Recruiting | No outcome recorded |
| Phase 2 | NCT07121322 | Jul 2025 → Jul 2027 expected | germ cell tumor | National Cancer Institute, Slovakia | Recruiting | No outcome recorded |
| Phase 2 | NCT04785066 | Aug 2022 → Aug 2025 | ischemic stroke | Fondation Ophtalmologique Adolphe de Rothschild | Completed | No outcome recorded |
| Phase 2 | NCT05203224 | Feb 2022 → Nov 2025 | ischemic stroke | University of Melbourne | Completed | No outcome recorded |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT04402944 | Jul 2020 → Dec 2021 | COVID-19 | Boston Children's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04359654 | Jun 2020 → Aug 2021 | COVID-19 | University College, London | Completed | Met primary |
| Phase 2 | NCT04432987 | May → Aug 2020 | COVID-19 | Acibadem University | Unknown | No outcome recorded |
| Phase 2 | NCT04445285 | Apr 2020 → Nov 2021 overdue | COVID-19 | Jon Simmons | Recruiting | No outcome recorded |
| Phase 2 | NCT01952470 | Oct 2013 → Aug 2017 | disease related to solid organ transplantation, respiratory tract infectious disorder | The Alfred | Completed | No outcome recorded |
| Phase 2 | NCT00416182 | Dec 2006 → Jun 2012 | cystic fibrosis, sinusitis | University of Vermont | Completed | Missed primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT00502632 | Oct 2007 → Oct 2009 | pleural empyema | Azienda Ospedaliera di Padova | Unknown | No outcome recorded |
| Phase 2/3 | NCT00204685 | Aug 2003 → Jul 2006 | — | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 36 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04402970 | Jun → Dec 2020 | COVID-19, acute respiratory distress syndrome | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 3 | NCT04459325 | Jun → Jul 2020 | COVID-19 | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT04355364 | Apr 2020 → Dec 2021 | COVID-19, acute respiratory distress syndrome | Fondation Ophtalmologique Adolphe de Rothschild | Terminated | Missed primary |
| Phase 3 | NCT03368092 | Mar 2019 → Sep 2027 expected | adult acute respiratory distress syndrome | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 3 | NCT01155752 | Jul 2013 → Jun 2014 | cystic fibrosis, sinusitis | Milton S. Hershey Medical Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT00534079 | Sep 2007 → Feb 2009 | chronic rhinosinusitis, cystic fibrosis | University of Jena | Completed | Met primary |
| Phase 45 trials | ||||||
| Phase 4 | NCT07592520 | Apr 2026 → Apr 2027 expected | pleural empyema | Dartmouth-Hitchcock Medical Center | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05139901 | Dec 2021 → Feb 2023 | pneumonia | University Medical Centre Ljubljana | Terminated | No outcome recorded |
| Phase 4 | NCT00843817 | Apr 2009 → Apr 2013 | cystic fibrosis | University Hospital, Tours | Completed | No outcome recorded |
| Phase 4 | NCT00680316 | Jun 2008 → May 2009 | cystic fibrosis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00434278 | Mar 2007 → Nov 2008 | cystic fibrosis | Genentech, Inc. | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04915586 | Dec 2019 → Dec 2020 | pleural empyema | National University of Malaysia | Completed | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT03586076 Comparator | Jan → Jun 2018 | — | JHL Biotech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01357447 Comparator | May 2011 → Mar 2012 | Sjogren syndrome | UConn Health | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05880524 Comparator | Oct 2026 → Mar 2028 expected | inflammatory disease, ischemic stroke | Ludwig-Maximilians - University of Munich | Recruiting | No outcome recorded |
| Phase 2 | NCT00117208 Comparator | Nov 2005 → Feb 2008 | cystic fibrosis | Syntara | Completed | No outcome recorded |
| Phase 3 | NCT04468100 Comparator | Aug 2017 → May 2018 | cystic fibrosis | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT00265434 Comparator | Dec 2005 → May 2006 | chronic rhinosinusitis, cystic fibrosis | University of Jena | Completed | No outcome recorded |
| Phase 4 | NCT01712334 Comparator | Dec 2012 → Jun 2013 | cystic fibrosis | Genentech, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01356147 Comparator | May 2011 → Jan 2015 | respiratory tract infectious disorder | Georgetown University | Completed | No outcome recorded |
| Phase 4 | NCT02168387 Comparator | Dec 2010 → May 2012 | lung disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00419380 Comparator | Jan 2007 → May 2011 | otitis media | University of Colorado, Denver | Completed | No outcome recorded |
| — | NCT05279391 Comparator | Oct 2020 → Nov 2021 | respiratory failure | Democritus University of Thrace | Unknown | No outcome recorded |
| — | NCT00671723 Comparator | Oct 2006 → Jul 2008 | lung disorder | University of Oklahoma | Completed | No outcome recorded |
| — | NCT01095276 Comparator | Nov 2005 → Jan 2006 | lung disorder | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
Press releases naming this drug 7 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 44 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dornase alfa | “Though intraplerual alteplase/ dornase alfa and normal saline have been established method to reduce complicated pleural infection sizes and rate of surgical interventions,...” NCT07592520 ↗30“Dornase alfa, a recombinant DNAse 1, has been proposed to attenuate these effects by degrading extracellular DNA and enhancing alveolar clearance of NETs.” PMID 41125713 ↗ Oct 2025 “The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate, and 8.77 mg/mL sodium chloride.” NCT01155752 ↗ “Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis” NCT00265434 ↗ “Nebulised dornase alfa \[2.5 mg BID\] for 7 days” NCT04459325 ↗ “intrapleural dornase alfa and tPA administered” NCT02135588 ↗ |
| Known as | deoxyribonuclease I | “Dornase alfa is a recombinant human deoxyribonuclease I (DNase I) approved for use in cystic fibrosis, where it enzymatically degrades extracellular DNA and reduces mucus viscosity.” NCT07121322 ↗ |
| Known as | DNase | “intrapleural 10 mg alteplase (t-PA) with 5 mg of pulmozyme (DNase) twice daily for 72 h were used.” PMID 35581627 ↗ May 20221“Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)” NCT02135588 ↗ |
| Known as | DNAse alfa | “DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme” NCT05139901 ↗ |
| Known as | DNase I | “Dornase alfa is a recombinant human deoxyribonuclease I (DNase I) approved for use in cystic fibrosis, where it enzymatically degrades extracellular DNA and reduces mucus viscosity.” NCT07121322 ↗ |
| Known as | dornase | “The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes.” NCT00419380 ↗ |
| Known as | Dornase alfa recombinant human deoxyribonuclease I (rhDNase) | “Dornase alfa recombinant human deoxyribonuclease I (rhDNase)” NCT01155752 ↗ |
| Known as | dornase alpha | “Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis.” NCT00204685 ↗4“PULMOZYME contains an active substance called dornase alpha as an active substance.” NCT04432987 ↗ |
| Known as | Pulmozyme | “Dornase alfa (Pulmozyme®, Roche, Switzerland) will be administered by aerosol, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days, using a vibrating mesh...” PMID 32560746 ↗ Jun 202019“Evaluation of the Efficacy of Dornase Alfa (Pulmozyme®) on Arterial Recanalization in Post-thrombectomy Angiography in Patients With Ischemic Stroke by Thrombolysis and...” NCT04785066 ↗ “2.5 mg of DNase (Dornase alpha, PULMOZYME® , Genentech, South San Francisco, CA), nebulized twice daily, after a 15 min premedication with nebulized albuterol (2.5 mg diluted...” NCT00671723 ↗ “Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.” NCT03368092 ↗ “The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear drop Floxin® (ofloxicin) to dissolve clogged tubes.” NCT00419380 ↗ “In humans, recombinant DNAse (dornase alfa, Pulmozyme®) has marketing authorization for inhaled administration in cystic fibrosis.” NCT06723717 ↗ “DNAse alfa (Pulmozyme®, Roche) is a recombinant human enzyme” NCT05139901 ↗ “Dornase Alfa Inhalation Solution [Pulmozyme]” NCT04359654 ↗ “dornase alfa [Pulmozyme®]” NCT01712334 ↗ “Dornase alfa (Pulmozyme)” NCT00534079 ↗ “Pulmozyme” NCT04402970 ↗ |
| Known as | Recombinant human deoxyribonuclease (rh-DNase) | “Patient will receive 2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.” NCT04445285 ↗ |
| Known as | Recombinant human deoxyribonuclease I | “Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis.” NCT00204685 ↗ |
| Known as | rh-DNase | “Patient will receive 2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses.” NCT04445285 ↗1“Recombinant human deoxyribonuclease I (rhDNase, dornase alpha), administered by inhalation, is currently used as a mucolytic agent in the treatment of cystic fibrosis.” NCT00204685 ↗ |
| Known as | rhDNase, pulmozyme | “rhDNase, pulmozyme” NCT00117208 ↗ |
| Modality | Protein / enzyme biologic | “recombinant human deoxyribonuclease (rhDNase), the current best established mucolytic treatment” PMID 19996349 ↗ Dec 2009 |
| Route | Inhaled | “nebulised rhDNase alone” PMID 19996349 ↗ Dec 2009 |